Catalyst Pharmaceuticals Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 9, 2024

There are 10 speakers on the call.

Operator

Greetings, and welcome to the Catalyst Pharmaceuticals First Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Cobb, Chief Financial Officer.

Operator

Thank you, sir. You may begin.

Speaker 1

Thank you. Good morning, everyone, and thank you for joining our conference call to discuss Catalyst's Q1 2024 financial results and business highlights. Richard Daley, President and CEO will be leading the call today and Jeffrey Del Carmen, our Chief Commercial Officer and I will also be presenting. Additionally, Doctor. Stephen Miller, our Chief Operating Officer and Chief Scientific Officer will be available for the Q and A.

Speaker 1

Before we begin, I would like to remind you that in our remarks this morning and in the Q and A session, we will make statements about expected future results, which may be forward looking statements for purposes of federal securities laws. These statements relate to our current expectations, estimates estimates and projections and are not guarantees of future performance. They involve risks, uncertainties and assumptions that are difficult to predict and may not prove to be accurate. Actual results may vary from the expectations contained in our forward looking statements. These forward looking statements should be considered only in conjunction with the detailed information contained in our SEC filings, including the risk factors described in our 2023 Annual Report on Form 10 ks filed with the SEC on February 28, 2024, and in our Q1 2024 Quarterly Report on Form 10 Q, which was filed yesterday with the SEC.

Speaker 1

At this time, I'll turn the call over to Rich.

Speaker 2

Thanks, Mike. Welcome to the Catalyst Q1 2024 Financial Results Call. Today, we will discuss our excellent performance in the Q1 as well as our continued focus on execution, provide an update on clinical and regulatory milestones, delve into our portfolio diversification approach and finally provide insight into our continued delivery on financial discipline. In Q1 'twenty four, we delivered another quarter of strong performance with total revenues of $98,500,000 This performance along with our January equity raise enhanced our substantial cash position, which totaled 310 $400,000 as of March 31, 2024. During the quarter, our agility and focus on execution enabled our team to respond to opportunities in the market and drive continued growth in Firdapse, successfully launch Agamri and deliver on consistent performance for Fi Compa.

Speaker 2

I want to congratulate our team for continuing to meet the challenging targets we set for them. We are poised for promising growth as demonstrated by the significant milestones achieved. Firdapse continues to deliver strong double digit growth, a tremendous testament to our ability to drive the sustained success of the brand for more than 5 years. Additionally, we successfully launched the Gamry for Duchenne's muscular dystrophy or DMD on March 13. Just over 2 weeks of launch performance are included in our Q1 financials.

Speaker 2

We are very excited by Agyemri's performance and potential when reviewing Agyemri's uptake trends. Based on physician and patient response, we are experiencing a great deal of momentum and this speaks to the tremendous market conditioning we did prior to the launch, as well as our ability to successfully integrate a gamma ray into our quick Catalyst Pathways patient services infrastructure. Although it's early in the launch, we believe a gamma ray is positioned for significant step up in Q2 and beyond. Jeff will provide further details about product performance during his discussion. Let's transition to product development and regulatory.

Speaker 2

For AGAMRI, we are preparing to launch our previously reported long term registry study of AGAMRI, which we have rebranded as the SUMMIT study. This study aims to gather long term patient safety and quality of life data, offering a deeper understanding of the product's potential long term benefits for patients. We recognize that a fundamental challenge in the traditional steroid use in treating DMD is in the safety impact for the long term use of these steroids. Long term effects can cause doctors and patients to number 1, delay initiation of steroids number 2, dose too low to accrue the therapeutic benefits of steroids and number 3, discontinue steroid use too early. We have initiated the SUMMIT study designed in accordance with FDA guidance for the use of real world data to evaluate the long term safety and quality of life benefits of AGAMRI.

Speaker 2

The AGAMRI profile may offer patients and physicians the opportunity to start therapy sooner, optimize the effective dose and stay on therapy longer, with the goal of potentially improving the care of patients with DMD. Moving on to Firdapse. We are eagerly awaiting the June 4, 2024 PDUFA date of our supplemental new drug application seeking to increase the Firdapse baximod daily dose from 80 milligrams to 100 milligrams. If our sNDA is approved, we believe that it creates the potential to provide increased therapeutic flexibility for patients and the physicians who treat them. Internationally, we continue to work with our partner in Japan, Daito Pharma, as they await word from Japanese regulatory authorities on the Firdapse Japan NDA that they filed late last year and with the decision expected around the end of Q3 beginning of Q4 this year.

Speaker 2

Next, regarding business development and portfolio diversification. We are working on 3 fronts to increase our BD opportunities. 1st, expanding our portfolio. We are aggressively exploring opportunities to expand our portfolio in this orphan CNS and orphan adjacent spaces. We are taking a comprehensive approach to decision making, ensuring alignment with our overarching strategy for optimal success and our long term vision.

Speaker 2

2nd, we are working to expand our partnerships. We are actively pursuing opportunities to expand the partnerships for Firdapse in the APAC region beyond Japan and looking to enter agreements in LatAm. There is a recognized need for LEMS treatment options like Firdapse in both regions. Additionally, we are pursuing partnerships for a gamma ray with ex U. S.

Speaker 2

Partners in North America. 3rd, we are exploring opportunities to diversify and expand the use of our existing products through life cycle management. Our teams are fully immersed in developing an Agamir life cycle plan seeking to open up new avenues for growth for this product and we expect to provide an update on this project during the second half of this year. Our accomplishments in the Q1 reflect our strong performance with steady product revenue contributions and a promising product launch, further adding to our financial strength and driving our growth. We are grateful to our team for delivering excellent results this quarter, which gives us further confidence as we reaffirm our full year 2024 total revenue guidance in the range of $455,000,000 to $475,000,000 Mike will provide additional details on our financial performance during his discussion today.

Speaker 2

Since the outset of 2024, we have surged forward with formidable momentum, laying down solid groundwork to drive short and long term value. We remain excited about the journey ahead. I'll now turn over the call to Jeff Del Carmen, who will provide an overview of our commercial performance. Jeff?

Speaker 3

Thanks, Rich, and good morning, everyone. Fueled by the successful execution of our strategic growth initiatives across our entire commercial portfolio, we are exceedingly pleased with our Q1 2024 performance. As Rich mentioned, Catalyst had an excellent start to 2024, driven by the combination of sustained organic growth of Firdapse, stable revenues from Fycompa and the strong initial commercial launch of AGAMRI. Q1 total net product revenues of $98,400,000 positions Catalyst well to achieve our 2024 full year total revenue guidance. First, let me start with Firdapse.

Speaker 3

Q1 2024 net sales were $66,800,000 representing a 16% increase over the same quarter last year, in line with our forecasted growth projections, a direct result of a sustained cadence of new patient starts, high compliance and consistent low discontinuation rates. Net new patients in Q1 2024 were the highest total since Q1 2022. We believe that these facts demonstrate that our underlying Firdapse business is solid. Prescription approval rates were greater than 90% across all payers, government or private commercial insurers. As expected, net product revenues in the Q1 reflected the typical Q1 seasonality and the reset of deductibles and co pays at the beginning of the year.

Speaker 3

In addition, some new patient and refill prescription adjudications were temporarily impacted by the change healthcare cyber attack, particularly in February. Given the intensely symptomatic nature of LEMS, we exercise Catalyst no patient left behind approach and provided 5 days of free drug to any Firdapse patient who could not fill their prescription. It is our mission to ensure continuity of care for the patients we serve, and we believe that what we did supports that commitment. I am also glad to report that at the end of the day, we subsequently received reimbursement for all the 5 day bridge prescriptions provided. The Firdapse refill rate was temporarily affected in February, but we saw rapid rebound in filled prescriptions in March back to historic norms.

Speaker 3

Our strategic growth initiatives will continue to drive organic growth moving forward. We maintain a pipeline of approximately 500 LEMS patients in various stages of their diagnostic journey that are not yet on Firdapse. Tracking these LEMS patients is a prime reason for our ability to consistently deliver 15% to 20% annual growth, as half our new patient enrollments typically come from this group. Furthermore, LEMS education programs targeting healthcare providers have already resulted in consistently higher voltage gated calcium channel antibody testing rates, which will shorten the diagnostic journey for LEMS patients and lead to more patients being eligible for treatment with Firdapse. Now let me provide an update on Fycompa.

Speaker 3

We achieved solid Q1 net revenues of 30,400,000 further fortifying our revenue diversification. We expect continued stable net revenues for the rest of 2024. Further, all epilepsy regional account managers have been trained on Firdapse and LEMS and moving forward, these RAMs will conduct secondary calls with healthcare providers that account for the 40 percent overlap in Fycompa and Firdapse physician call points, further increasing Firdapse's share of voice and the ability to identify new LEMS patients. Let's turn to AGAMRI. We successfully commercially launched AGAMRI on March 13.

Speaker 3

Early indicators of new patient enrollments show strong interest, exceeding initial expectations. This is primarily due to penetration of both the Emflaza and the prednisone patient segments. Payer approval rates are greater than 90%, averaging less than 30 days to approval. Based on our experience with Firdapse, we expect this to improve over time. Further, to date, 63% of the DMD Centers of Excellence have enrolled at least one patient on a gamma ray.

Speaker 3

Since most of the prescriptions for DMD patients are written by doctors who practice in these centers of excellence, we believe this is a very positive sign for the acceptance of a gamma ray. In summary, we believe that we are making meaningful progress on sustained organic growth for Firdapse continuing to generate stable net revenues for Fycompa and exceeding our expectations for our revenues for a gamma ray. We are highly focused on continued commercial execution excellence and leveraging our strategies to maximize our demonstrated capabilities. I want to thank the entire team at Catalyst for their unwavering commitment to patients and look forward to continuing with a successful 2024. I will now turn the call back over to Mike.

Speaker 1

Thank you, Jeff. As Wirtz noted, our performance during the Q1 of 2024 has set us on pace for another strong year, driven by our solid financial performance, financial discipline and strong execution. We remain steadfast in our commitment to driving growth, leveraging strategic partnerships and expanding our portfolio to capitalize in emerging opportunities throughout the year. We intend to continue our commitment to grow through strategic partnerships and portfolio expansion in 2024. To support this objective in January 2024, Catalyst sold 10,000,000 shares of its authorized but unissued common stock to raise net proceeds of approximately $140,700,000 for the purposes of funding potential future acquisitions and for general corporate purposes.

Speaker 1

Our total revenues for the Q1 of 2024 were $98,500,000 an approximate 15% increase when compared to total revenues of $85,400,000 for the Q1 of 2023. Product revenue net for our lead product Firdapse were $66,800,000 a 16% increase year over year compared to $57,500,000 in Q1 2023. Product revenue net for the Q1 of 2024 for Vycompa increased to $30,400,000 compared to $27,800,000 for the portion of the Q1 of 2023 in which we recognized revenue following our acquisition of the product rights in late January of 2023. As a reminder, we anticipate that 2024 revenue for FICOMO will be affected by differences in variable consideration compared to 2023 when revenues were booked under a size cost arrangements with distributors and government agencies. Effective January 1 this year, these costs are tied to arrangements between the company and those distributors and agencies, which are higher.

Speaker 1

Finally, we launched the Gammari in mid March and for the short time during the Q1 that the product was commercially available, product revenue net was $1,200,000 In the Q1 of the calendar year, like many companies in our industry, we are by the reset of patient insurance deductibles. Further in the Q1 of 2024, we reported expenses related to our annual commitment to make charitable contributions to foundations that fund LEMS patient support programs throughout the year. Cost of sales was approximately $12,500,000 in the Q1 of 2024 compared to $9,900,000 in the Q1 of 2023 and consisted principally of royalties. As a reminder, royalties for Firdapse increased by 3% when net product sales exceed $100,000,000 in any calendar year. As a result, we expect cost of sales to trend higher as this year progresses.

Speaker 1

Additionally, I would like to note that the gamma ray also carries a royalty in the range of low double digits to mid-twenty percent depending on sales achievements within a calendar year. Further details on our royalty obligations for Gamry are reported in our Q1, twenty twenty four Form 10 Q. Research and development expense was $2,600,000 in the Q1 of 2024, slightly down from $3,600,000 in the Q1 of 2023. At this point, as noted in the 2024 guidance we provided earlier this year, we believe that R and D expense SG and A expenses

Speaker 2

for the Q1

Speaker 1

of 2024 totaled $46,900,000 compared to $29,700,000 in Q1 2023. SG and A expenses moderately increased as a percentage of total operating expenses to 66% for Q1 2024 compared to 60% for Q1 2023. The overall difference in SG and A expenses in the Q1 of 2024 was principally due to the incremental selling and marketing expenses to support the launch of AGAMRI and operating expenses for Fycompa being present for a full quarter in Q1 2024 when compared to approximately 2 thirds of Q1 2023, as well as the non cash stock based compensation charges of $3,900,000 relating to the retirement of the company's former CEO and CFO based on the terms of their respective separation agreements with the company. Our effective tax rate for the Q1 of 2024 was 20% compared to 20.8% for the Q1 of 2023. Although lower in the Q1 of 2024, we still expect our annualized effective tax rate to be slightly higher than the annual effective tax rate in full year 2023 of 24.4%.

Speaker 1

For 2024, the difference to the statutory federal income tax rate of 21% was primarily driven by state income taxes and anticipated annual permanent differences. The effective tax rate is affected by many factors including the number of stock options exercised in any given period is likely to fluctuate in future periods. Net income before income taxes for the Q1 of 2024 was $29,100,000 a 22% decrease year over year compared to $37,300,000 for the Q1 of 2023. We reported GAAP net income for the Q1 of 2024 of $23,300,000 or $0.20 per basic and $0.19 per diluted share, a decrease of 21% year over year compared to GAAP net income for the Q1 of 2023 of $29,600,000 or $0.28 per basic and $0.26 per diluted share. The decrease in both net income before income taxes and GAAP net income reflects a full quarter of operating expenses pertaining to Fycompa as well as substantial incremental operating expenses to prepare for the launch of a gamma ray.

Speaker 1

It also includes one time non cash stock based compensation expense that I mentioned earlier. Non GAAP net income for the Q1 of 2024 was $46,800,000 or $0.40 per basic and $0.38 per diluted share, which excludes from GAAP net income, amortization of intangible assets related to our acquisitions of Fycompa, Agamory and Resurgi of $9,300,000 stock based compensation expense of $8,200,000 the income tax provision of $5,800,000 and depreciation of $86,000 This compares to non GAAP net income in the Q1 of 2023 of $46,800,000 or $0.44 per basic and $0.41 per diluted share, which excludes from GAAP net income amortization of intangible assets related to our acquisitions of FICOMPA and Resurgi of $6,500,000 stock based compensation expense of $2,900,000 the income tax provision of $7,700,000 and depreciation of $69,000 As previously reported, we ended the Q1 of 2024 with cash and cash equivalents of $310,400,000 compared to $137,600,000 at December 31, 2023. The increase in cash of 100 $72,800,000 was largely driven by our January 2024 capital raise, which added approximately $140,700,000 in net cash proceeds. The remaining increase in cash is driven primarily by $31,900,000 in cash generated from business operations. We believe our current funds continue to allow us the financial flexibility to fund our existing R and D programs, meet our potential contractual obligations and support our strategic initiatives, business development and portfolio expansion efforts, leading to long term growth and value creation.

Speaker 1

More detailed information and analysis of our Q1 2024 financial performance may be found in our quarterly report on Form 10 Q, which was filed with the Securities and Exchange Commission yesterday, May 8, and can be found in our Investor Relations page on our website at www.catalystpharma.com.

Speaker 2

And with that, I will turn the call back over to Rich. Thanks, Mike. At Catalyst, our mission is Resolute, to pioneer 1st in class innovative medicines for patients with rare and difficult to treat diseases. With an expanding portfolio of commercial products and a track record of operational excellence, we are primed for ongoing success in delivering transformative therapies to the market. We look forward to providing updates on our continued progress.

Speaker 2

At this time, we'll turn the call back over to the operator, and we look forward to answering your questions. Thank you.

Operator

Thank you. We will now be conducting a question and answer session. Our first question comes from the line of Joon Lee with Truist Securities. Please proceed with your question.

Speaker 4

Hi, this is Jeremy on for Joon. Thanks for taking our questions. Can you just share any specific doc or patient feedback on the Gomory experience? And then any further updates on your BD plans? How far along are you in that search?

Speaker 4

And is there a specific therapeutic area you're targeting such as epilepsy? Thanks.

Speaker 3

Thanks for the question. Jeff, do you want to handle the first part? Sure. It's a little early to get some specific feedback about physicians and the efficacy that their patients are seeing with a gamma ray. What we can tell you is the physicians and the patients are extremely happy with the process to get on a Gamri and to get drug.

Speaker 3

So that's 1st and foremost. But we do anticipate feedback about their patients here shortly.

Speaker 2

Great. And as to the second part of the question, so we are aggressively pursuing opportunities as we mentioned on the call in the orphan space and what we call the orphan adjacent. So we believe our infrastructure is one that really supports patient care. So when you think about what we did in the quarter and really making sure that our patients had uninterrupted care, I think it really speaks to the strategic advantage we have as a company. So we believe that our infrastructure supports essentially any orphan opportunity.

Speaker 2

And so we are out aggressively seeking opportunities across the orphan space. We believe what we're seeing our success, our continued success, our ongoing success with Firdapse and our burgeoning success with the GammaRay really supports that. So we are looking pretty far and wide on the in the orphan space. So we're I would say we're pretty essentially agnostic because we believe that our infrastructure would support just about any orphan opportunity.

Operator

And our next question comes from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question.

Speaker 5

Hey, good morning, Rich and team. Thanks for taking the question and congratulations on a nice quarter start of the year. I had a couple of them, 1 on a gamma ray, 1 on Firdapse and then one on BD. So on a gamma ray, you mentioned new patient enrollments, very good to hear. Can you give us some color on where you're taking patients from?

Speaker 5

Is it more Emflaza or is it more prednisone? And any color on that as well as the pacing of information from the new SUMMIT study? Thanks.

Speaker 2

Great. So Charles, great. Thanks for the questions. And Jeff, do you want to handle the first part of the question and we'll have Steve handle the second part? Sure.

Speaker 2

Good morning, Charles. When we

Speaker 3

look at the enrollments that we're getting so far for a Gamry, 47% of our new enrollments are from patients that were currently on Emflaza. 43% of our patients were coming from patients that were on prednisone. And there are just a handful or a smaller percentage that were naive patients to any corticosteroid.

Speaker 2

And then Charles, your second question, I believe you said the pacing of information from the SUMMIT study. Is that correct? Yes. Yes. Steve, do you want to handle that?

Speaker 6

Sure. Thank you, Rich, and thank you, Charles. The SUMMIT study is scheduled to be a 5 year study. We anticipate doing analyses approximately once a year, but it would depend on the nature and significance of findings that we observed during the course of the study. At the very least, the information will be published and made available to the medical information staff and at the most it will be submitted to the FDA under the FDA's guidance for real world data and its use for updating product labeling.

Speaker 5

Okay. That's helpful. And then quickly on Firdapse, looking forward to the PDUFA date, possible dose expansion. Could you remind us of call it roughly what percentage of patients are at maximum dose and how that decision if it is positive to expand dosing might impact demand for Firdapse?

Speaker 3

So Charles, currently 40% of Firdapse patients, active Firdapse patients are on a daily dose of 80 milligrams, which is the maximum. There are another 4% of patients that are on a dose greater than 80 milligrams, which they work directly with the specialty pharmacy to get that approved. So we do think that there's significant upside there for patients to find their optimal dose. And over time, we expect the average daily dose, which is currently at around 61 milligrams a day to go up to approximately 65 milligrams or 66 milligrams. That is over time we expect for maybe the next the following 12 months post expansion of the label to get to that average daily dose increase.

Speaker 5

Got it. Final question, BD, going back to the prior question, it seems like you're busy with a gamma ray launch. I guess is despite the interest in additional assets, is there a goal for doing that in 2024 Or is that really dependent on the opportunity set?

Speaker 2

It's a great question, Charles. We will we continue under Preeti's leadership to consider a number of opportunities. I would say primary is to get Gamry off the launch pad, which I think we're doing a great job getting it off the launch pad, but we want to be sure we have the right opportunity. Want to build on the CNS franchise. We want to continue to look and see where the opportunities are in the marketplace and do the right deal at the right time.

Speaker 2

And we want to be sure that we take advantage of those opportunities that come our way. I think we can do additional deals, but the timing and the right deal has to be right for us. So we're going to play it smart to benefit the patients, take advantage of the talent in the organization and obviously benefit the shareholders.

Operator

And our next question comes from the line of Jason Gerberry with Bank of America. Please proceed with your question.

Speaker 7

Hey, guys. Thanks for taking my question. One BD question for me and then one a gamma ray question. Just on BD front, I'm just curious if there's a general profile range in terms of size of deal on stage development that you look at? Would you be willing to bring in an asset that wouldn't deliver sales and profit in the short term and how Firdapse litigation outcomes sort of shape your M and A aperture?

Speaker 7

And then on a Gamry, maybe a little surprised just to hear lifecycle management discussion this early in the launch. Is this something that you update in the second half that could be beneficial within the IP window of a Gamry or the regulatory exclusivity window of a gamma ray or something that's kind of a longer term IP extending approach? If you can comment on that, that'd be great. Thanks.

Speaker 2

Thank you. Thanks for the questions. So on the BD size and opportunity, so we would look for things at this point in our company's life cycle for things that are immediately accretive or nearly immediately accretive. We would want to take advantage of the balance sheet that Mike talked about in the call. So when we think about size and opportunity, we would want to be really thoughtful.

Speaker 2

We want to look at things that could add to the company's balance sheet immediately. So I think we would stay within ourselves, if you will. I don't want to commit to a size at this point in time. I think we would, again, assess. But really looking at those things that are very close to market or are on market.

Speaker 2

And again, to continue to build the breadth of our capabilities so that we can continue to build and look at larger opportunities in the future as a buy and build company. That's what we want to do. We want to build our presence in the market. On the how the Firdapse litigation colors our thought on that, right now, Steve can speak to the timing of that, but we assume that we're going to have a significant runway with Firdapse and Firdapse sales. And so we can we have an opportunity to build our portfolio, and we're going to take full advantage of that as we can do that for the time being.

Speaker 2

Regarding life cycle management, we believe now is the time to be looking at opportunities for a gamma ray to build a portfolio of applications for the product in rare and orphan conditions that require a steroid. We want to be that steroid of choice. And in the companies I've worked in, in the past, typically companies wait too long to think about those things. And so to your point about is it going to be something that's applicable within the window of IP for a gamma ray, That's exactly the point. That's what we're trying to do is make sure that we can get the studies done, identify those opportunities, get the studies done and then take advantage of it and create value for patients and create value for shareholders as well.

Operator

Our next question comes from the line of Samantha Simenkow with Citi. Please proceed with your question.

Speaker 8

Good morning. This is Eric on for Sam. Thanks for taking our questions. What do you think is driving the high percentage of patients switching from prednisone in your early launch? And how do you see that evolving as this progresses?

Speaker 3

Thanks for your question. We do think that the conversion from prednisone over to a Gammari is basically because of the safety profile. And many of these patients have been on prednisone for significant amount of time and have seen or experienced those side effects and they're looking to they transitioned over to safety profile. So over time, we do expect this mix to be about what it is today, which is very encouraging. Initially during planning and forecasting, we expected the initial launch to be primarily from the Emflaza patients or those patients that were used to being on a branded corticosteroid.

Speaker 3

We are encouraged by this because now we're now opened up to the entire corticosteroid market for boys living with DMD and that's what we're seeing and that's what we expect moving forward. Thank you.

Operator

Our next question comes from the line of Joe Canaccaro with Piper Sandler. Please proceed with your question.

Speaker 9

Hey, Everybody, thanks so much for taking my questions. I have a few on Agamri. If I recall correctly, I think you had said there were about 28 patients in the EAP program. Wondering if you could just sort of speak to what percent of those patients have been able to transition to commercial reimbursed drug? And then maybe if you could also sort of speak to the current cadence of intake forms, maybe how the current rate compares to your pre launch experience where you indicated there was a sort of indication of significant pent up demand.

Speaker 9

So wondering if current cadence of intake forms sort of continues to point to that pent up demand? Thanks. And I have maybe one follow-up.

Speaker 2

Jeff, do you want to take that?

Speaker 3

Sure. So I can point to first about the cadence of the enrollments. We started accepting pre commercial launch enrollments in December, and we saw significant pent up demand. We also knew at that time that there were the centers of excellence that were waiting for an announcement of the official commercial launch date. So they were holding some enrollments until that announcement.

Speaker 3

Post announcement, we started releasing volume increase that validated our confidence in the launch. And since the commercial launch, we continue to see steady enrollments that are steady at a high level, higher than what we had forecasted, which is very encouraging. And Joe, can you remind me of your first question about the

Speaker 9

EAP patients, sort of what percent have been able to transition to commercial reimbursed drug?

Speaker 3

Correct. Of the 28, over half of those patients are on reimbursed shipments right now and the rest are still in process.

Speaker 9

Okay, great. And then maybe my follow-up on still on Algomery, you guys have mentioned a step up in 2Q that you're expecting. Maybe you could just help contextualize that a little bit. How much of that will be driven by patients already on drug seeing a full 3 months of treatment versus expectations around new patient starts? Thanks again for taking my questions.

Speaker 2

Sure. So just to start off, as Jeff mentioned, we saw this nice curve of patients enrolling prior to launch and physicians were waiting. And then with the announcement of the launch, we did see an increased enrollment, which was great. So we expect this rollover to happen. And as Jeff mentioned in his comments, it takes about currently taking about 4 weeks to convert these patients from enrollment to reimbursed.

Speaker 2

That's going to roll over into the Q2. So we're really excited about that. And these physicians waiting to for the launch, obviously, now we're going to see that impact in the Q2. But Jeff, do you want to take the rest

Speaker 3

of it? Well said and well stated, Rich. And just to add on to that, we do expect the current positive payer landscape to improve even more over time. So that 4 weeks that Rich mentioned, we expect that to reduce within 6 months. We do potentially see it to about 1 to 2 weeks from time of complete enrollment to reimburse shipment.

Speaker 3

That's our expectation. And then the other part is balanced by a significant volume of enrollments that we continue to see. So on both ends is where we why we have confidence in that step up in Q2.

Speaker 9

Okay, great. Thanks again.

Speaker 2

Thank you.

Operator

Thank you. Thank you. We have reached the end of our question and answer session. And with that, this concludes today's teleconference. You may disconnect your lines at this time.

Operator

Thank you for

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